The Spanner™ Temporary Prostatic Stent - P060010
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: The Spanner™ Temporary Prostatic Stent
PMA Applicant: AbbeyMoor Medical, Inc.
Address:501 East Soo Street , Parkers Prairie, MN 56361
Approval Date: December 14, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060010a.pdf
What is it? The Spanner™ temporary prostatic stent is a sterile, disposable device, positioned in the prostatic urethra from the bladder neck to the external urinary sphincter. The stent portion of The Spanner™ prevents collapse of the prostatic urethra and allows urine to drain from the bladder. The Spanner™ is held in position by a balloon in the bladder and by a soft anchor in the urethra.
How does it work? The Spanner™ is designed to facilitate urination following minimally invasive treatment for prostate enlargement, also called benign prostatic hyperplasia (BPH). Following these treatments, the prostate swells temporarily increasing obstruction requiring short-term catheterization (3-10 days). Following catheter removal the obstructive swelling may continue or worsen. The Spanner™ supports the prostatic urethra during the recovery period following removal of the initial catheter while allowing the patient to urinate normally. The appropriate Spanner™ size for the patient is determined using the Surveyor™ accessory device.
When is it used? The Spanner™ is intended for temporary use (up to 30 days) to maintain urine flow and allow voluntary urination in patients following minimally invasive treatment for benign prostatic hyperplasia (BPH) and after initial post-treatment catheterization.
What will it accomplish?In a clinical study, patients using The Spanner™ after removal of their catheters experienced a modest improvement in their lower urinary tract symptoms compared to patients who did not use The Spanner™ after removal of their catheters. Patients using The Spanner™ had less urine remaining in their bladders after voiding than patients who did not use The Spanner™. Adverse events with The Spanner™ were comparable to patients who did not use The Spanner™. The most common complaints that required treatment were bacteria in the urine, urinary tract infection, burning during urination, urinary retention, pain, urinary frequency, and device movement. Device movement or clot blockage can cause urinary retention in patients using The Spanner™.
When should it not be used? The Spanner™ stent should not be used in patients with a positive urine culture or active urinary tract infection, a history of symptomatic urinary tract disease that could affect the function of the stent, surgery altering the normal uro-genital anatomy or abnormal urethral anatomy that affects the function of the lower urinary tract, or a prostatic urethral length for which there is not an appropriately sized The Spanner™.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p060010
Information on benign prostatic hyperplasia (BPH): http://kidney.niddk.nih.gov/kudiseases/pubs/prostateenlargement/index.htm